苦碟子注射液安全性再评价中的急毒及长毒研究  

Toxical research of Kudiezi injection in safety re-evaluation

作　　者：李志强[1] 詹君[1] 常艳鹏[2,3] 王秀英[4] 李淑华[4] 焉媛媛[4] 魏汉莲 

机构地区：[1]沈阳双鼎制药有限公司,辽宁沈阳110179 [2]中国中医科学院博士后流动站,北京100700 [3]中国中医科学院中医临床基础医学研究所,北京100700 [4]辽宁省食品药品检验所,辽宁沈阳110021 [5]辽宁省中药研究所,辽宁沈阳110161

出　　处：《中国中药杂志》2012年第18期2828-2830,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030)"中药上市后评价关键技术研究"

摘　　要：目的:观察1 d多次给予苦碟子注射液对小鼠产生的毒性反应,及多日连续重复给药对大鼠产生的毒性反应。方法:苦碟子注射液0.04 mL.g-1小鼠尾静脉注射给药,给药3次;20,10,4 mL.g-1大鼠尾静脉注射给药,每日1次,连续6周。结果:1 d多次给药小鼠无异常。大剂量多日给药对大鼠血液学、血液生化学有一定影响,部分动物出现肝、肾轻微病变,注射局部出现出血、水肿及炎性反应。结论:苦碟子注射液以临床人用剂量的180倍给予小鼠尾静脉注射,未发现毒性反应。连续重复大剂量给药,引起大鼠病变的主要靶器官可能为肾脏、肝脏,但从恢复期结果看,对肝、肾脏的毒性呈可逆性,未见毒性作用。大剂量长期给药对局部有一定的刺激性。提示本品用药应在医师指导下进行,并注意更换注射部位。此研究为苦碟子注射液临床使用提供了安全性依据。Objective： To explore the toxic effect on mouse administrated Kudiezi injection multy times a day, and on rats repeat administrated for many days. Method： Mouse tail intravenous injection of Kudiezi, 0.04 mL . g-1 , 3 times a day, rats tail intra- venous injection of Kudiezi, 20,10,4 mL . kg-1, once a day, for 6 weeks. Result： There is no abnormal to the mouses administrated many times a day. The rats administrated large doses of drug for many days have certain effects on hematology, blood biochemistry. Some animals appear liver, kidney lesions mild, injection local appear haemorrhage, edema and inflammatory reaction. Conclusion： The mouse which was intravenous injection in the dose of 180 times Kudiezi injection as much as people used, revealed no toxicity reaction. Repeated large-dose administration, rats caused by lesions of the main target organs may be for kidney, liver. But the recovery result on liver, kidney toxicity was reversible, no delayed toxicity. At the same time, large doses of long-term administration of local have a certain irritation. Tips the medication should be under the guidance of doctors, and pay attention to replace the injection site. This research will provide safety basis for the clinical use of Kudiezi injection.

关 键 词：苦碟子注射液 安全性 静脉注射给药 重复给药 毒性反应 长毒 急毒 轻微病变 

分 类 号：R286.0[医药卫生—中药学]